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    Clinical Trial Results:
    A Double-Blind, Placebo-Controlled, Parallel-Group, Multicentre, Multiregional, One Year Study to Assess the Efficacy and Safety of Twice Daily Oral Rifaximin Delayed Release Tablets for Induction of Clinical Remission with Endoscopic Response at 16 Weeks followed by Clinical and Endoscopic Remission at 52 Weeks in Subjects with Active Moderate Crohn’s Disease

    Summary
    EudraCT number
    		 2014-001645-24
    Trial protocol
    		 HU   CZ   DE   PL   FR  
    Global end of trial date
    06 Oct 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Jul 2019
    First version publication date
    19 Jul 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RECD3126
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02240108
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Salix Pharmaceuticals, Inc
    Sponsor organisation address
    400 Somerset Corporate Blvd, Bridgewater, United States, NJ 08807
    Public contact
    Study Director, Clinical Affairs: John Lahey, Salix Pharmaceuticals, Inc, +1 908-541-8631, John.Lahey@bauschhealth.com
    Scientific contact
    Study Director, Clinical Affairs: John Lahey, Salix Pharmaceuticals, Inc, +1 908-541-8631, John.Lahey@bauschhealth.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    06 Oct 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Oct 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Oct 2017
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To determine the efficacy of Rifaximin EIR (extended intestinal release) 800 mg twice daily (BID) vs. placebo for the induction of clinical remission and endoscopic response following 16 weeks of treatment in subjects presenting with active moderate Crohn’s disease.
    Protection of trial subjects
    This study was conducted in compliance with the study protocol and in accordance with Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects, and with Good Clinical Practice (GCP), as required by the US Code of Federal Regulations applicable to clinical studies (21 CFR Parts 11, 50, 54, 56 and 312, 42 USC 282(j), International Conference on Harmonization, Harmonized Tripartite Guideline E6 (R1): GCP and E2A: Safety Data Management, and applicable local regulations. To ensure the safety of patients on placebo, subjects were allowed to continue stable doses of oral 5-ASA, mercaptopurine, azathioprine, and/or methotrexate as concomitant therapies throughout the study.
    Background therapy
    		 No background therapy was specified. Subjects were allowed to continue stable doses of oral 5-ASA, mercaptopurine, azathioprine, and/or methotrexate as concomitant therapies throughout the study.
    Evidence for comparator
    		 The comparator in this study was an inactive placebo.
    Actual start date of recruitment
    28 Oct 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Czech Republic: 10
    Country: Number of subjects enrolled
    France: 4
    Country: Number of subjects enrolled
    Hungary: 2
    Country: Number of subjects enrolled
    United States: 64
    Worldwide total number of subjects
    80
    EEA total number of subjects
    16
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    73
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Men and women aged ≥18 years, with moderate, non-fistulising Crohn’s disease in ileum or colon with a Crohn’s Disease Activity Index (CDAI) score of ≥220 and ≤450 points prior to randomisation; and a Simple Endoscopic Score for Crohn’s Disease (SES-CD) score of ≥7. Exclusion criteria: ulcerative or indeterminate colitis, celiac disease.

    Pre-assignment
    Screening details
    		 During Screening, eligible subjects had an average daily score of >1.5 for abdominal pain (CDAI Item 2) and average daily count of >1.5 for liquid/very soft stools (CDAI Item 1).

    Period 1
    Period 1 title
    Treatment period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst
    Blinding implementation details
    Rifaximin EIR was supplied as pink, coated, oval, biconvex tablets. Matching placebo was supplied as tablets that were identical in appearance to Rifaximin EIR tablets with inactive ingredients. Subjects were assigned to treatment groups by the means of a centralised electronic randomization system in a 1:1 allocation to either rifaximin or matching placebo.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Rifaximin EIR 800 mg
    Arm description
    		 Two x 400 mg tablets twice a day (total daily dose 800 mg)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rifaximin EIR
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    800 mg rifaximin EIR twice a day for up to 52 weeks

    Arm title
    		 Placebo
    Arm description
    		 Placebo comparator arm
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo matching rifaximin EIR tablets administered twice daily for up to 52 weeks

    Number of subjects in period 1
    		Rifaximin EIR 800 mg Placebo
    Started
    35
    45
    Completed
    21
    21
    Not completed
    14
    24
         Consent withdrawn by subject
    5
    10
         Physician decision
    3
    2
         Adverse event, non-fatal
    1
    9
         Not reported
    2
    1
         Pregnancy
    1
    -
         Lost to follow-up
    1
    1
         Lack of efficacy
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Rifaximin EIR 800 mg
    Reporting group description
    		 Two x 400 mg tablets twice a day (total daily dose 800 mg)

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo comparator arm

    Reporting group values
    		 Rifaximin EIR 800 mg Placebo Total
    Number of subjects
    		 35 45 80
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 43.5 ( 14.85 ) 43.2 ( 12.97 ) -
    Gender categorical
    Units: Subjects
        Female
    		 19 24 43
        Male
    		 16 21 37
    CDAI score
    Crohn's Disease Activity Index at baseline
    Units: Score
        arithmetic mean (standard deviation)
    		 305.4 ( 69.51 ) 300.0 ( 56.39 ) -
    SES-CD score
    Simple endoscopic score for Crohn's disease at baseline.
    Units: Score
        arithmetic mean (standard deviation)
    		 12.0 ( 5.01 ) 11.7 ( 4.61 ) -
    Duration of disease
    Duration of Crohn's disease at baseline.
    Units: Years
        arithmetic mean (standard deviation)
    		 10.5 ( 8.57 ) 9.6 ( 9.53 ) -

    End points

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    End points reporting groups
    Reporting group title
    Rifaximin EIR 800 mg
    Reporting group description
    		 Two x 400 mg tablets twice a day (total daily dose 800 mg)

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo comparator arm

    Primary: Change in CDAI Item 1 (Week 16)

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    End point title
    		 Change in CDAI Item 1 (Week 16) [1]
    End point description
    Clinical symptom remission defined by (1) the total number of liquid/very soft stools for the 7 days prior to the Week 16 visit being ≤ 10 (from CDAI Item 1).
    End point type
    Primary
    End point timeframe
    From baseline to Week 16.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis is presented because the study was terminated prematurely, at which point there were only 80 patients randomised (rather than the 660 overall).
    End point values
    		 Rifaximin EIR 800 mg Placebo
    Number of subjects analysed
    35
    45
    Units: Subjects
        ≤ 10 liquid/ very soft stools
    6
    8
    No statistical analyses for this end point

    Primary: Abdominal pain rating (Week 16)

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    End point title
    		 Abdominal pain rating (Week 16) [2]
    End point description
    An abdominal pain rating of ≤ 1 on each day for the 7 days prior to the Week 16 visit
    End point type
    Primary
    End point timeframe
    From baseline to Week 16.
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis is presented because the study was terminated prematurely, at which point there were only 80 patients randomised (rather than the 660 planned overall).
    End point values
    		 Rifaximin EIR 800 mg Placebo
    Number of subjects analysed
    35
    45
    Units: Subjects
        pain rating of ≤ 1
    19
    15
    No statistical analyses for this end point

    Primary: Change in CDAI Item 1 and abdominal pain rating (Week 16)

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    End point title
    		 Change in CDAI Item 1 and abdominal pain rating (Week 16) [3]
    End point description
    Number of liquid/very soft stools for the 7 days prior to the week 16 visit being ≤ 10 and an abdominal pain rating of ≤ 1 on each day for the 7 days prior to the week 16 visit.
    End point type
    Primary
    End point timeframe
    From baseline to Week 16.
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis is presented because the study was terminated prematurely, at which point there were only 80 patients randomised (rather than the 660 planned overall).
    End point values
    		 Rifaximin EIR 800 mg Placebo
    Number of subjects analysed
    35
    45
    Units: Subjects
        ≤ 10 liquid/ soft stools and pain rating of ≤ 1
    5
    7
    No statistical analyses for this end point

    Primary: Endoscopic response (Week 16)

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    End point title
    		 Endoscopic response (Week 16) [4]
    End point description
    Endoscopic response defined as a ≥ 3-point decrease in the SES-CD from baseline to the SES-CD score obtained between Week 16 and Week 17.
    End point type
    Primary
    End point timeframe
    From baseline up to Week 16/17.
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis is presented because the study was terminated prematurely, at which point there were only 80 patients randomised (rather than the 660 overall).
    End point values
    		 Rifaximin EIR 800 mg Placebo
    Number of subjects analysed
    35
    45
    Units: Subjects
        ≥ 3-point decrease in SES-CD
    10
    10
    No statistical analyses for this end point

    Primary: Change in CDAI Item 1 (Week 52)

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    End point title
    		 Change in CDAI Item 1 (Week 52) [5]
    End point description
    Clinical symptom remission defined by (1) the total number of liquid/very soft stools for the 7 days prior to the Week 52 visit being ≤ 10 (from CDAI Item 1).
    End point type
    Primary
    End point timeframe
    From baseline to Week 52.
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis is presented because the study was terminated prematurely, at which point there were only 80 patients randomised (rather than the 660 planned overall).
    End point values
    		 Rifaximin EIR 800 mg Placebo
    Number of subjects analysed
    35
    45
    Units: Subjects
        ≤ 10 liquid/ very soft stools
    7
    3
    No statistical analyses for this end point

    Primary: Abdominal pain rating (Week 52)

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    End point title
    		 Abdominal pain rating (Week 52) [6]
    End point description
    An abdominal pain rating of ≤ 1 on each day for the 7 days prior to the Week 52 visit.
    End point type
    Primary
    End point timeframe
    From baseline to Week 52.
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis is presented because the study was terminated prematurely, at which point there were only 80 patients randomised (rather than the 660 planned overall).
    End point values
    		 Rifaximin EIR 800 mg Placebo
    Number of subjects analysed
    35
    45
    Units: Subjects
        pain rating of ≤ 1
    9
    5
    No statistical analyses for this end point

    Primary: Change in CDAI Item 1 and abdominal pain rating (Week 52)

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    End point title
    		 Change in CDAI Item 1 and abdominal pain rating (Week 52) [7]
    End point description
    Number of liquid/very soft stools for the 7 days prior to the Week 52 visit being ≤ 10 and an abdominal pain rating of ≤ 1 on each day for the 7 days prior to the Week 52 visit.
    End point type
    Primary
    End point timeframe
    From baseline to Week 52.
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis is presented because the study was terminated prematurely, at which point there were only 80 patients randomised (rather than the 660 planned overall).
    End point values
    		 Rifaximin EIR 800 mg Placebo
    Number of subjects analysed
    35
    45
    Units: Subjects
        ≤ 10 liquid/ soft stools and pain rating of ≤ 1
    6
    1
    No statistical analyses for this end point

    Primary: Endoscopic response (Week 52)

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    End point title
    		 Endoscopic response (Week 52) [8]
    End point description
    Endoscopic response defined as a ≥ 3-point decrease in the SES-CD2 from baseline to the SES-CD score obtained at Week 52.
    End point type
    Primary
    End point timeframe
    From baseline to Week 52.
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis is presented because the study was terminated prematurely, at which point there were only 80 patients randomised (rather than the 660 overall).
    End point values
    		 Rifaximin EIR 800 mg Placebo
    Number of subjects analysed
    35
    45
    Units: Subjects
        ≥ 3-point decrease in SES-CD
    9
    15
    No statistical analyses for this end point

    Secondary: Induction of Clinical Remission (Week 16)

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    End point title
    		 Induction of Clinical Remission (Week 16)
    End point description
    Induction of clinical remission defined as a CDAI score of less than 150 points at Week 16.
    End point type
    Secondary
    End point timeframe
    From baseline to Week 16.
    End point values
    		 Rifaximin EIR 800 mg Placebo
    Number of subjects analysed
    35
    45
    Units: Subjects
        CDAI score < 150 points
    17
    12
    No statistical analyses for this end point

    Secondary: Total number of liquid/very soft stools and daily abdominal pain score (Week 52)

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    End point title
    		 Total number of liquid/very soft stools and daily abdominal pain score (Week 52)
    End point description
    The total number of liquid/very soft stools being ≤ 10 and a daily abdominal pain score of ≤ 1 for the 7 days prior to the visit in ≥ 80% of the study visits during the 52-week treatment period.
    End point type
    Secondary
    End point timeframe
    From baseline to Week 52.
    End point values
    		 Rifaximin EIR 800 mg Placebo
    Number of subjects analysed
    35
    45
    Units: Subjects
        ≤ 10 liquid/very soft stools and pain score of ≤ 1
    2
    3
    No statistical analyses for this end point

    Secondary: SES-CD Score of 0 at Week 52

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    End point title
    		 SES-CD Score of 0 at Week 52
    End point description
    Proportion of Subjects with SES-CD Score of 0 at Week 52
    End point type
    Secondary
    End point timeframe
    At Week 52.
    End point values
    		 Rifaximin EIR 800 mg Placebo
    Number of subjects analysed
    35
    45
    Units: Subjects
        Score of 0
    0
    3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were reported from time of signing informed consent until the end of the follow-up period (2 weeks after last treatment).
    Adverse event reporting additional description
    Occurrences of AEs or SAEs were reported during each study visit or by the subject outside of scheduled visits.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Rifaximin EIR 800mg
    Reporting group description
    		 Two x 400 mg tablets twice a day (total daily dose 800 mg).

    Reporting group title
    Placebo
    Reporting group description
    		 Inactive placebo tablets matching rifaximin EIR twice daily.

    Serious adverse events
    		 Rifaximin EIR 800mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 35 (17.14%)
    9 / 45 (20.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Hodgkin's disease
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung adenocarcinoma
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Overdose
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention postoperative
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Peripheral ischaemia
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Coronary artery disease
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Seizure
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Pregnancy
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Barrett's oesophagus
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Crohn's disease
         subjects affected / exposed
    0 / 35 (0.00%)
    3 / 45 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea haemorrhagic
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Odynophagia
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 35 (0.00%)
    2 / 45 (4.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Prostatitis
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 35 (2.86%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Rifaximin EIR 800mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    25 / 35 (71.43%)
    25 / 45 (55.56%)
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 45 (0.00%)
         occurrences all number
    4
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 35 (8.57%)
    5 / 45 (11.11%)
         occurrences all number
    3
    5
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 35 (8.57%)
    1 / 45 (2.22%)
         occurrences all number
    3
    1
    Lymphadenopathy
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 45 (0.00%)
         occurrences all number
    3
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    2 / 35 (5.71%)
    2 / 45 (4.44%)
         occurrences all number
    2
    2
    Pain
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 45 (0.00%)
         occurrences all number
    2
    0
    Pyrexia
         subjects affected / exposed
    2 / 35 (5.71%)
    2 / 45 (4.44%)
         occurrences all number
    2
    2
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 35 (5.71%)
    7 / 45 (15.56%)
         occurrences all number
    2
    7
    Abdominal pain upper
         subjects affected / exposed
    4 / 35 (11.43%)
    2 / 45 (4.44%)
         occurrences all number
    4
    3
    Crohn's disease
         subjects affected / exposed
    3 / 35 (8.57%)
    7 / 45 (15.56%)
         occurrences all number
    3
    8
    Diarrhoea
         subjects affected / exposed
    4 / 35 (11.43%)
    5 / 45 (11.11%)
         occurrences all number
    5
    6
    Nausea
         subjects affected / exposed
    3 / 35 (8.57%)
    4 / 45 (8.89%)
         occurrences all number
    3
    4
    Rectal haemorrhage
         subjects affected / exposed
    0 / 35 (0.00%)
    4 / 45 (8.89%)
         occurrences all number
    0
    4
    Vomiting
         subjects affected / exposed
    4 / 35 (11.43%)
    4 / 45 (8.89%)
         occurrences all number
    4
    4
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 45 (0.00%)
         occurrences all number
    2
    0
    Rash
         subjects affected / exposed
    2 / 35 (5.71%)
    4 / 45 (8.89%)
         occurrences all number
    2
    5
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 35 (8.57%)
    3 / 45 (6.67%)
         occurrences all number
    3
    3
    Back pain
         subjects affected / exposed
    3 / 35 (8.57%)
    2 / 45 (4.44%)
         occurrences all number
    3
    3
    Pain in extremity
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 45 (0.00%)
         occurrences all number
    2
    0
    Infections and infestations
    Gastroenteritis viral
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 45 (0.00%)
         occurrences all number
    2
    0
    Nasopharyngitis
         subjects affected / exposed
    4 / 35 (11.43%)
    1 / 45 (2.22%)
         occurrences all number
    7
    1
    Pharyngitis streptococcal
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 45 (0.00%)
         occurrences all number
    2
    0
    Sinusitis
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 45 (0.00%)
         occurrences all number
    2
    0
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 35 (5.71%)
    2 / 45 (4.44%)
         occurrences all number
    2
    2
    Urinary tract infection
         subjects affected / exposed
    0 / 35 (0.00%)
    3 / 45 (6.67%)
         occurrences all number
    0
    3
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    1 / 35 (2.86%)
    3 / 45 (6.67%)
         occurrences all number
    1
    3
    Type 2 diabetes mellitus
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 45 (0.00%)
         occurrences all number
    2
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    06 Oct 2017
    The trial was prematurely discontinued due to difficulty in enrollment and lack of clinical study drug access.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The study was terminated early due to difficulty in enrollment and lack of clinical study drug access. The efficacy results are not considered definitive and are considered for exploratory purposes only.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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